510(k) Report

Devices descending from K170373

4 later devices reach Flextra Steerable Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193509AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc.20203—
+2K210685AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20212—
+3K233691FlexCath Cross Transseptal SolutionAcutus Medical, Inc.20230—
+3K220047AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20220—